insulin lispro 6 days versus insulin aspart 6 days in pump use

Conditions: Diabetes Mellitus, Type 1

Summary: this is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. the purpose of this study is to provide information on the use of insulin lispro in insulin pumps (continuous subcutaneous insulin infusion \[csii\]) compared to insulin aspart over 6 days of pump reservoir in-use. the study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes (world health organization criteria) for at least 24 months. * treated with continuous subcutaneous insulin infusion therapy for the previous 6 months. * mean total daily insulin dose for 3 days prior to screening equal to or less than 46 units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180 unit reservoir. * baseline body mass index (bmi) less than or equal to 35.0 kg/m\^2. * baseline glycosylated hemoglobin (hba1c) 5% to 9%. exclusion criteria: * impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter \[mg/dl\]). * legal blindness. * have had any episode of hypoglycemic coma, seizures, or disorientation in the 12 months prior to screening. * have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (bg) less than 45 mg/dl) in the 12 months prior to screening. * have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening. * have had a pump-related infusion site abscess in the 12 months prior to screening. * have had multiple, clinically significant occlusions as judged by the investigator. * have had any infection with staphylococcus aureus in the past 5 years. * have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary. * patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago. * have had a blood transfusion or severe blood loss within 3 months prior to screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with hba1c methodology. * are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding screening. * have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator's opinion. * have known hypersensitivity or allergy to any of the study insulins or their excipients. * are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * have previously completed or withdrawn from this study after having signed the informed consent document (icd). * are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.